What Does Johnson & Johnson Have Against Patient Safety?

This year is not turning out well for Johnson & Johnson. Things wouldn’t be so grim for the huge conglomerate-which markets a range of products from gauze to baby shampoo to surgical implants-if its priority were patient safety instead of hawking products it knows to be deficient.

The first piece of bad news for J&J was delivered by a jury in Atlanta that ordered the company to pay more than $11 million in punitive and compensatory damages to a former hospice nurse. Her misfortune was having surgery to implant vaginal mesh sold by a J&J subsidiary. The mesh was supposed to support pelvic muscles and internal organs but proved so harmful that the patient underwent 18 subsequent surgeries to relieve the resulting pain.

As recounted in a story on MedCityNews.com, the nurse missed so much work because of the surgeries that she was fired.

The device was first sold by J&J in 2005, and was withdrawn from the market last year because there were so many problems and so many lawsuits. According to the MedCity story, thousands of implant cases have been filed against several different manufacturers of vaginal implants, and this was only the second verdict. Both were in favor of the plaintiffs.

The civil justice website Pop Tort noted last year that the FDA had approved surgical meshes for procedures like abdominal surgery. But J&J was marketing them to women with pelvic prolapse-when muscle and organs lose their strength and resilience, often as a result of childbirth. The mesh was supposed to offer support and treat prolapse problems such as incontinence. What it did was disintegrate, grow into tissue and become impossible to remove. Some patients were severely injured, and some died.

McNeil Consumer Healthcare, the J&J branch that manufacturers several of its products including the recalled vaginal mesh implant, shuttered the plant that made it in 2010. It won’t reopen until a federal judge approves.

Still, after the damage award the company claimed that the implant was not defective in design, that J&J did not misrepresent the product to surgeons and that the jury was confused. That sure sounds like “blame the messenger.”

Also in February, as Pop Tort reported, the U.S. attorney’s office and the Justice Department were investigating J&J’s marketing of its DePuy ASR hip replacement, which we’ve written about before. It was recalled in 2010 after data revealed that as many as 30 in 100 such artificial hips would fail within the first six years. And because it’s a metal-on-metal device, it also posed risks of poisoning the people who received it as tiny bits of metal eroded into surrounding tissue.

Before it was recalled, according to AboutLawsuits.com, more than 90,000 implants had been sold throughout the world.

The first trial went to the jury at the end of February after witnesses who used to work for DePuy testified that the company knew the product was deficient long before it was recalled. Last Friday, the verdict was announced: Johnson & Johnson was ordered to pay $8.3 million in damages.

Some 10,000 lawsuits have been filed over the ASR device. And several other metal-on-metal hip implants have demonstrated similar problems-the FDA has told doctors that they should be considered only if other artificial hip implants weren’t appropriate. Future metal-on-metal designs must undergo extensive human trial before they’re allowed to be sold.

On March 1, according to Pop Tort, the FDA announced a Class I recall-the most serious class, denoting “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”-of J&J’s LPS Diaphyseal Sleeve. It’s used in reconstructive knee surgery. The device, said the FDA, has the “potential for fractures,” which could lead to loss of function, loss of limb, infection, compromised soft tissue or death. The agency has received 10 reports of the device malfunctioning:

Clearly, something is rotten in the state of Johnson & Johnson. As Pop Tort suggested, “From now on, Johnson & Johnson needs to stick to cotton swabs. The outer ear is as far inside the body we would like J&J products to go, thank you very much.”

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